BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2052644 · Received April 7, 2011

    Report

    Report Number
    3007566237-2011-02666
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ABOUT 2 YEARS THE PATIENT'S STIMULATOR WOULD NOT GIVE RELIEF FROM THE PAIN. AS A RESULT IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention